Indicia informative of characteristics of insertable medical devices

ABSTRACT

A system by which resource information relating to an insertable medical device, such as an intravascular catheter, can be identified by its source so as to be accessed by a practitioner, caregiver, or patient, is disclosed. In particular, a resource information key is included at a predetermined key location on or proximate to the medical device, wherein the key indicates the source of the resource information. In one example embodiment, therefore, an insertable medical device for establishing intravascular access to a patient, such as a peripherally inserted central catheter (“PICC”), is disclosed and comprises: an internal portion, and a portion external to the patient that includes a resource information key indicating a website where a user can acquire resource information relating to the medical device. In other embodiments indicia are provided as quick response (“QR”) codes, and as various markings to indicate compatibility of the medical device with ethanol.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/937,302, filed Nov. 8, 2007, and titled “ResourceInformation Key for an Insertable Medical Device,” which claims thebenefit of U.S. Provisional Patent Application No. 60/864,806, filedNov. 8, 2006, and titled “Medical Device Uniform Resource Identifier.”This application also claims the benefit of U.S. Provisional PatentApplication No. 61/614,939, filed Mar. 23, 2012, and titled “IndiciaInformative of Ethanol Locking Capability in a Catheter.” Each of theaforementioned applications is incorporated herein by reference in itsentirety.

BRIEF SUMMARY

Manufacturers of medical devices, including those configured forinsertion into the body of a patient, generally make every effort toensure that each device is accompanied by a comprehensive collection ofprinted and other material intended to ensure that the device is placedand used correctly. Examples of such devices include peripherallyinserted central catheters (“PICCs”), dialysis catheters, peripheralcatheters, central venous catheters (“CVCs”), access ports, and otherdevices designed to provide vascular access to the patient.

Despite the above-mentioned efforts, however, situations may arise wherefurther information regarding a particular medical device is desired orneeded in order for the device to be properly employed. For instance,the accompanying medical device documentation may be misplaced or lost,or further information may be released after the device was manufacturedand distributed. Such information may be needed by the practitionerplacing the medical device in the patient, or by the patient orcaregiver after device insertion. In these or other cases, it may bedifficult for the practitioner, patient, or caregiver to readily acquireneeded information relating to the device.

In light of the above discussion, therefore, a need exists for asolution that overcomes the above-identified challenges relating to theavailability of medical device information for insertable medicaldevices.

Embodiments of the present invention have been developed in response tothe above and other needs in the art. Briefly summarized, theseembodiments are directed to a system by which resource informationrelating to an insertable medical device, such as an intravascularcatheter, can be identified by its source so as to be accessed by apractitioner, caregiver, or patient. In particular, a resourceinformation key is included at a predetermined key location on orproximate to the medical device, wherein the key indicates the source ofthe resource information.

In one example embodiment, therefore, an insertable medical device forestablishing intravascular access to a patient, such as a peripherallyinserted central catheter (“PICC”), is disclosed and comprises: aninternal portion configured for intravascular insertion into thepatient, and a portion external to the patient. The exterior portion ofthe PICC includes a resource information key that is positioned at apredetermined key location. The resource information key indicates awebsite where a user can acquire the resource information relating tothe medical device.

In other embodiments, an insertable medical device includes atwo-dimensional code, such as a quick response (“QR”) code that iselectronically readable so as to provide information regarding acharacteristic or other aspect of the medical device to a user or otherperson. In yet other embodiments, various indicia are disclosed forindicating to a user a particular characteristic of the medical device,such as its compatibility with respect to ethanol and otheralcohol-based fluids.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a top view of a peripherally inserted central catheter(“PICC”) partially inserted in the arm of a patient, thereby depictingone example of an insertable medical device that benefits from thepresent invention according to one embodiment thereof;

FIG. 2 is a perspective view of the PICC of FIG. 1 before insertion intoa patient, including a resource information key according to oneembodiment;

FIG. 3 is a close-up top view of a portion of the PICC of FIG. 2,showing further details of the resource information key;

FIG. 4 is a top view of a connector portion of the PICC of FIG. 2,showing a resource information key location according to one embodiment;

FIG. 5 is a top view of a clamp portion of the PICC of FIG. 2, showing aresource information key location according to one embodiment;

FIG. 6 is a top view of a bifurcation hub portion of the PICC of FIG. 2,showing a resource information key location according to one embodiment;

FIG. 7 is a top view of a catheter portion of the PICC of FIG. 2,showing a resource information key location according to one embodiment;

FIG. 8 is a top view of a portion of the PICC of FIG. 2, including ahang tag having a resource information key location according to oneembodiment;

FIG. 9 is a perspective view of a PICC coupled with a stabilizationdevice having a plurality of resource information key locationsaccording to one embodiment;

FIG. 10 is a top view of a PICC and stabilization device together with adressing having a plurality of resource information key locationsaccording to one embodiment of the present invention;

FIG. 11 is a perspective view of a dual septum implantable access port,depicting an example of an implantable medical device that benefits fromthe present invention according to one embodiment thereof;

FIG. 12 is a bottom view of the dual septum implantable access port ofFIG. 11, including a reversed radiopaque resource information keyaccording to one embodiment of the present invention;

FIG. 13A is a perspective view of a catheter assembly including a codedindicium according to one embodiment;

FIG. 13B shows a sample QR code as a coded indicium according to oneembodiment;

FIG. 14 is a top view of the bifurcation of the catheter assembly ofFIG. 13A, showing the coded indicium;

FIG. 15 is a perspective view of an access port including a codedindicium according to one embodiment;

FIG. 16 is a top view of an access port including a coded indiciumincluded on a septum thereof according to one embodiment;

FIG. 17 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 18 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 19 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 20 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 21 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 22 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 23 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 24 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 25 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 26 is a perspective view of a portion of a catheter assemblyincluding certain indicia according to one embodiment;

FIG. 27 shows various symbols that may serve as indicia according to oneembodiment; and

FIG. 28 is a bottom view of a radiopaque insert for use with animplantable port and including certain indicia according to oneembodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the invention, and are not limiting of the presentinvention nor are they necessarily drawn to scale.

I. Resource Information Key

FIGS. 1-10 depict various features of embodiments of the presentinvention, which is generally directed to a system by which resourceinformation relating to an insertable medical device, such as anintravascular catheter device, can be identified so as to be accessed bya practitioner, caregiver, or patient.

Reference is first made to FIG. 1, which depicts a medical device,generally designated at 10, that is configured for insertion into a body12 of a patient. In particular, the medical device 10 depicted in FIG. 1is a dual lumen peripherally inserted central catheter (“PICC”), and isshown inserted in the arm of the patient body 12. Also shown in FIG. 1is a resource information key location, to be described more fullybelow, generally indicated at 50.

It should be noted that, though the accompanying drawings depict a PICCdevice, other medical devices that are at least partially inserted intothe patient can also benefit from the principles of the presentinvention to be described herein. Examples of such devices includedialysis catheters, peripheral catheters, cannulas, infusion sets, andother devices designed to enable intravascular access to the patient. Inyet other embodiments, completely implantable devices, such assubcutaneous access ports, can also employ embodiments of the presentinvention. As such, the breadth of the present invention should not beconstrued as being limited to the medical devices explicitly depictedand described herein.

Reference is now made to FIG. 2, depicting in further detail the PICCshown in FIG. 1 before placement in a patient, here shown at 20.Comparison of FIG. 2 with FIG. 1 will reveal that the PICC 20 includesan internal portion 20A for insertion into the vasculature of a patientand an external portion 20B that remains outside of the body of thepatient during PICC use. As embodiments of the present invention can beapplied to other insertable medical devices, the internal and externalportions of other devices would be varied according to the particulardesign of the insertable medical device. As shown, the PICC 20 generallyincludes a catheter 22, an extension leg assembly 24, and a bifurcationhub 26 that operably interconnects the catheter to the extension legassembly.

In further detail, the extension leg assembly 24 is configured to enablethe infusion or aspiration of fluids to or from the patient vasculaturevia the catheter 22 and bifurcation hub 26. The extension leg assembly24 includes a first connector 30 and second connector 32 that areconnected to a first extension tube 40 and a second extension tube 42,respectively. A first clamp 44 is included on the first extension tube40, and a second clamp 46 is included on the second extension tube 42.Note that more or fewer extension tubes could be included with the PICC20.

In accordance with one embodiment, a key is provided with the PICC 20 toenable further information relating to the PICC to be accessed by apatient, practitioner, caregiver, etc. Specifically, a resourceinformation key location (“RIKL”), generally indicated at 50, isprovided on the PICC 20. The RIKL 50 defines an area of the PICC 20where a resource information key 52 is located. As will be described,the resource information key 52 provides data to one as to a sourcewhere further information regarding the PICC 20 can be accessed. Notproviding the information itself, it instead acts as a “key,” enablingfurther PICC-related information to be located.

The contents of the resource information key 52 can be anyalpha-numeric, typographical, graphical content or other visual indiciathat can visually convey to the user the source where furtherinformation regarding the medical device can be found. As such, letters,numbers, graphical or other symbols, etc. may be used alone or incombination to form the resource information key 52. In yet anotherembodiment, the key could be identified not visually, but rather bypalpation.

For example, and as shown in greater detail in FIG. 3, the resourceinformation key 52 in one embodiment is implemented as a website uniformresource locator (“URL”), www.powerpicc.com, where a user can access viathe Internet various web pages giving further information regarding thestructure, use, precautions, or other aspects relating to the PICC 20.Such information may be beneficial to the user, or may be critical inorder to ensure patient safety, especially in instances where printedmaterial that originally accompanied the PICC 20 has been misplaced orlost, or when new information has become available regarding the PICC.

In light of the above discussion, it is appreciated that in accordancewith embodiments of the present invention the resource information key52 can take one of several forms, especially with regard to pointing theuser to an Internet-based resource. As such, examples of a resourceinformation key include a web address, URL, URI, IP address, etc., whichin turn direct the user to a location on the Internet where the furtherinformation may be found. Of course, the content of the resourceinformation key 52 can be varied according to the device on which it isfound.

As shown in FIGS. 2 and 3, the resource information key 52 is includedin the RIKL 50, which in turn is disposed on a portion of the secondextension tube 42. Generally, the RIKL 50 is chosen so as to be easilyviewable by the user. The RIKL 50 should also be sized large enough forthe resource information key 52 to be read without undue effort.Generally, locations proximally disposed on the external portion of themedical device are advantageous so as to enable the key to be readilyviewed. However, as will be seen in the additional example embodimentsto be discussed below, the key may be located at a variety of locationson the medical device. The resource information key 52 can be defined onthe RIKL 50 in a variety of ways, including etching, embossing,labeling, ink or other printing, etc.

As mentioned, though it is located on the second extension tube 42 inthe embodiments shown in FIGS. 1-3, the resource location key in otherembodiments can be positioned at other resource information keylocations on the PICC or other insertable medical device. FIGS. 4-8 givevarious examples of such alternative placement locations for theresource information key. In FIG. 4, for example, the RIKL 50 isdisposed on the first connector 30 of the extension leg assembly 24,while FIG. 5 shows the RIKL disposed on a cap 56 affixed to the firstclamp 44.

In FIG. 6, the RIKL 50 is disposed on an axial portion of thebifurcation hub 26. Alternatively, the RIKL can be disposed on one orboth of two suture wings 60 extending from the body of the bifurcationhub 26. In FIG. 7, the RIKL 50 is disposed on a proximal portion 22A ofthe catheter 22 that is not inserted into the patient. In FIG. 8, a hangtag 80 or other attachable component can be added to the PICC 20 toinclude the RIKL 50 thereon.

The embodiments shown in FIGS. 1-8 depict the RIKL 50 disposed on aportion of the PICC 20 itself. However, the RIKL may also be positionedon a component that is not part of, but typically used in conjunctionwith, the PICC 20 or other insertable medical device. In FIG. 9, forexample, a catheter stabilization device sold under the trademarkSTATLOCK® is shown at 90 and is commonly used to assist in securing thePICC 20 in place after insertion into the patient vasculature. Thestabilization device 90 includes a base 92 and a retention assembly 94for retaining the bifurcation hub 26 of the PICC 20. The retentionassembly 94 includes selectively closeable lids 96. FIG. 9 further showstwo possible areas for the RIKL 50: on a portion of the device base 92,and on one or both of the lids 96. Other areas could, of course, beemployed on the stabilization device 90 for positioning the RIKL 50.

FIG. 10 shows an adhesive dressing 100 that is commonly used to cover aportion of the PICC 20 and stabilization device 90 for increasedhygiene. The dressing 100 here includes two RIKLs 50 as yet anotherexample of possible locations for placement of the resource informationkey. It is appreciated that, in addition to the examples discussedabove, many other key locations could be devised on a variety ofinsertable medical devices, including devices that are fully implantedin the patient body, such as access ports, if desired. The presentinvention should not therefore be limited to only what is explicitlyshown and described herein.

FIGS. 11 and 12 depict the present invention as employed in yet anotherexample embodiment. In particular, FIGS. 11 and 12 depict a dual-septumaccess port 110 configured for subcutaneous implantation into the bodyof a patient. The access port 110 includes a first septum 112 covering afirst reservoir, and a second septum 114 covering a second reservoir.The reservoirs are defined by a body 116. The resource information key52 is disposed at a predetermined resource information key location 50on a bottom surface 118 of the access port body 116.

The key 52 in FIG. 12, “www.bardpp.com,” is positioned on the bottomsurface 118 in an inverse, or mirror-image, configuration. Further, thematerial used to define the key 52 includes a radiopaque material suchthat the key 52 is visible when a radiographic, or x-ray, image is takenof the implanted access port 110. The inverse key 52 in this case willappear non-inverse when the x-ray image is viewed, allowing theorientation of the implanted access port to be readily ascertained. Ofcourse, the key may be positioned in any one of a variety ofconfigurations, inverse or not, and locations on the access port.

The content of the key 52 can also serve to identify the access port 110in terms of type, size, manufacturer, etc., if desired. In addition, thekey 52 provides a source to which an observer can go to access furtherinformation regarding the access port 110, as in previous embodiments.Note that, while shown here in connection with a dual-septum accessport, single-septum or otherwise configured access ports, as well asother types of implantable medical devices, can also benefit from theprinciples described herein with regard to the present embodiment.

II. Coded and Ethanol-Related Indicia

Reference is now made to FIGS. 13A-14 in describing details ofidentifying indicia for a medical device according to one embodiment. Asshown, FIG. 13A depicts a medical device, namely a catheter 120,generally including a distal portion 120A and a proximal portion 120B.In detail, the catheter 120 includes a catheter tube 222 defining one ormore lumens. The catheter tube 222 defines two lumens, though the numberof lumens can vary. Each of two extension legs 224 of the catheter 120is in fluid communication with a respective one of the lumens of thecatheter tube 222. A bifurcation 226 fluidly connects the lumens of thecatheter tube 222 with the extension legs 224. Luer connectors 228 aredisposed on proximal ends of the extension legs 224. Also, clamps 230are disposed on the extension legs 224 to enable selective occlusionthereof.

In accordance with the present embodiment, a coded indicium 240 isincluded with the medical device shown here, i.e., the catheter 120. Thecoded indicium 240 is configured to provide information relating to acharacteristic, property, and/or quality of the catheter 120 or othermedical device with which it is associated. For instance, the codedindicium 240 can be utilized to access an Internet webpage or onlineresource, with a suitable Internet or web browser such as those found onsmart phones, laptop computers, Internet-connected devices, etc., so asto enable a user to acquire further information regarding the catheter120.

Examples of resources to which the coded indicium 240 can direct a userinclude: an Internet webpage giving further details and/or instructionsregarding the medical device; visual and/or multimedia information,including videos that described and or demonstrate use of the medicaldevice; instructional websites that direct a user how to insert, remove,and/or use the medical device; identification information regarding themedical device including type, size, manufacturer, etc.; warnings orofficial information promulgated by the manufacturer or an official orregulatory body; recently released or published information regardingthe medical device, etc. These and other resources and information canbe the targets to which a user is directed by the coded indicium 240.

In the present embodiment, the coded indicium 240 is implemented as atwo-dimensional coded symbol, such as a quick response (“QR”) code 242.Specifically, and as shown in FIGS. 13A and 14, the QR code 242 is atwo-dimensional matrix barcode and is included on a top portion of thebifurcation 226, a part of the proximal portion 120B of the catheter120. A relatively larger view of the QR code 242 is shown in FIG. 13B.Note that the QR code 242 can be included at a suitable location on thecatheter 120 in addition to what is shown in FIG. 13A, includingplacement of any of the components shown in FIG. 13A. The QR code 242can be added to the catheter 120 using any acceptable process, includingprinting, adhesive sticker, etching or engraving, insert molding, etc.In addition, the QR code 242 can be included on suitable medical devicesso as to be radioopaque, enabling identification of the medical devicevia x-ray imaging technology. Also, other two-dimensional coded symbolsin addition to QR codes can be included on the medical device to serveas a coded indicium, as appreciated by one skilled in the art.Similarly, the size and particular configuration of the QR code can varyfrom what is shown here.

The QR code 242 is encoded so as to be electronically scannable—alsoreferred to herein as machine readable or optically scannable—such thata device configured to scan and interpret QR codes can visually read theQR code and access the resource or information associated therewith forpresentation to the user. One example of such a device is a smartphonewith a camera that can take a picture of or otherwise electronicallyscan (such as via an optical scan) the QR code 242, then access theInternet or other portal so as to retrieve the resource or informationwith which the QR code is associated before presenting the resource orinformation to a user, such as on a display of the smartphone.Smartphones and other electronic devices commonly include, or can bemodified to include, suitable software or applications that enable QRcodes and other scannable codes to be imaged and interpreted. In anotherembodiment, a portable computer or special-purpose computing device canbe used to scan, interpret, and access the resource or informationassociated with the QR code.

As an example of the above, the catheter 120 including the codedindicium 240 as seen in FIG. 13A can be inserted into a patient in orderto establish vascular access. Before or after insertion of the catheter120, a user can electronically scan the QR code 242 with a smartphone orother suitable scanning device including the appropriate software orapplication. Once the QR code 242 has been scanned, thesoftware/application can convert the code to a uniform resource locator(“URL”) and direct a web browser on the smartphone to access a websiteor other Internet location and retrieve the resource and/or informationassociated with the QR code. The resource/information can includeinstructions for flushing the catheter 120, for instance. The resourceand/or information will be displayed on the smartphone display, enablingthe user to read and use information.

As mentioned, various other types of devices can be employed to scan,interpret, and present the QR code-associated information to the user.Also, in addition to remotely accessing information via the Internet orother source, other avenues for acquiring the information associatedwith the QR code can be employed, including accessing the informationlocally located on the smartphone or other scanning device itself.

FIGS. 15 and 16 show placement of the QR code 242 in accordance withother embodiments. In FIG. 15, an access port 260 is shown, including abody 262 and attached septum 264. A stem 266 extends from the port body262. The QR code 242 is shown in this embodiment located on a lateralside of the port body 262, where it may be scanned prior to placement ofthe access port 260 into the body of a patient to access thecorresponding information. In FIG. 16, the QR code 242 is positioned onthe septum 264. In one embodiment, the QR code 242 of FIG. 16 can beconfigured to be radiopaque so as to enable identification of the accessport 260 via the QR code 242 after the port has been subcutaneouslyimplanted within the body of a patient. Thus, it is appreciated that useof the QR code to facilitate the acquisition of furtherresources/information regarding one of a variety of medical devices iscontemplated.

Reference is now made to FIG. 17 in describing a medical deviceaccording to another embodiment. In particular, FIG. 17 shows a catheter320 including an elongate catheter tube 322 defining two lumens, thoughother lumen configurations are also possible. A proximal end of thecatheter tube 322 is operably attached to a bifurcation 326. A proximalend of the bifurcation 326 is operably attached to two extension legs324, each defining a lumen such that a fluid path is defined betweeneach extension leg and a corresponding lumen of the catheter tube 322.More or fewer extension legs can be included according to catheterdesign. Each extension leg 324 includes a corresponding luer connector328. A clamp 330 is also optionally included on each extension leg 324.

In accordance with the present embodiment, various indicia are includedwith the catheter assembly or other medical device to an observer apredetermined characteristic, quality, property, or other aspect of thecatheter assembly. In the embodiments described hereinbelow, thepredetermined characteristic includes compatibility of the catheter withalcohol-based solutions such as ethanol, e.g., the ability of ethanol tobe disposed within the catheter or extension leg lumens for a period oftime so as to “lock” (also referred to herein as “ethanol lock”) thecatheter and prevent clotting, sheath formation, and/or occlusion in ornear the tip of the catheter. The use of ethanol to lock the lumen(s) ofa catheter lumen is also useful for catheter infection prevention andtreatment. “Ethanol compatibility” and “ethanol locking” are both usedherein to indicate the ability of the catheter or other medical deviceto withstand the effects of such contact with ethanol (or otheralcohol-based fluids, in one embodiment) without unacceptably degradingthe catheter/device. In addition to indicating ethanol compatibility,the indicia to be described hereinbelow can indicate othercharacteristics, qualities, or properties of the catheter or medicaldevice. Thus, the discussion to follow should not be considered limitingin any way.

In light of the above, FIG. 17 shows an ethanol lock indicium(“indicium” or “indicia”) 340, according to one embodiment, forindicating ethanol compatibility of the catheter 10, including theability of the catheter to be locked with a solution containing liquidethanol. As shown, the indicium 340 in the present embodiment isimplemented as an indicator color 342A applied to the bifurcation 326 ofthe catheter 320 in combination with an alphanumeric marking 342Bincluded on the clamps 330 of the extension leg 324,

In greater detail, the indicator color 342A of the bifurcation indicatesto an observer in the present embodiment that the catheter assembly canbe locked with ethanol. Such indication is important, as not allcatheter assemblies are suitable for or can suitably withstand thepresence of ethanol. In the present embodiment, the indicator color 342Adisposed on the bifurcation 326 is yellow, though other colors may alsobe used to indicate this or another catheter/medical devicecharacteristic, quality, or property. In addition, in the presentembodiment the clamps 330 are also colored yellow to further indicateethanol compatibility. More, fewer, or other components of the catheteror suitable medical device may be colored with a predetermined color toindicate the characteristic, quality, or property of the device.

The alphanumeric marking 342B mentioned above serves in the presentembodiment as an additional component of the indicium 340, incombination with the bifurcation indicator color 342A. As shown in FIG.17, the alphanumeric marking 342B is disposed on each of the clamps 330and includes an alphanumeric message, namely, “EtOH,” a shorthanddesignation for ethanol. This indicates to an observer the compatibilityof the catheter 320 with ethanol.

In one embodiment, one or more of the catheter tube 322, bifurcation326, and extension legs 324 include an ethanol-resistant material, suchas an aromatic polycarbonate polyurethane that is also rated towithstand typical power injection pressures of about 190 psi. Othersuitable plastics can also be employed, including aromatic polyether,aliphatic polycarbonate, and aliphatic polyether polyurethanes. In oneembodiment, an ethanol solution of about 70% concentration is employedin locking the catheter 320, though other concentrations andformulations can be employed and indicated by the indicium.

It is appreciated that the indicator color and alphanumeric marking thatare included in the ethanol lock indicium of the present embodiment maybe used together or separately, placed on differing parts or componentsof the catheter or medical device, and may be configured differently, asdiscussed further below. Also as mentioned, the indicium may be used toindicate other characteristics, qualities, and/or properties of thecatheter or medical device. In the case of catheters, though the presentfigures show a PICC catheter, other catheter types can benefit from thepresent disclosure, including CVCs, tunneled and non-tunneled dialysiscatheters, peripheral IV catheters, etc. Further, the size and length,etc., can vary from what is shown and described.

FIG. 18 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented as an iconicmarking 352 placed on each of the clamps 330 of the extension legs 324.In the present embodiment, the iconic marking 352 includes an image of apadlock with a letter “e” superimposed on the padlock image. The clamps330 can optionally be colored to further indicate, as does the iconicmarking 352, compatibility of the catheter with ethanol for purposes ofethanol locking, for instance and as described above. The iconic marking352 is printed on each of the clamps 330 in the present embodiment,though other methods for placing the marking on the clamps can beemployed including placement of indicia on only one extension leg toindicate ethanol compatibility for that leg and corresponding catheterlumen only.

Note that the position, design, size, content, meaning, etc. of theiconic marking can be varied from what is shown and described here. Asan example of this, FIG. 19 shows the ethanol lock indicium 340implemented as a mixed marking 362 disposed on the clamps 330. The mixedmarking 362 includes both an iconic marking and an alphanumeric marking.In detail, the iconic portion of the mixed marking 362 includes theletter “e” superimposed atop an image of a padlock, as in FIG. 18. Thealphanumeric portion of the mixed marking 362 includes the shorthanddesignation “EtOH,” similar to the embodiment of FIG. 17. This and otherpossible combinations of indicia are therefore contemplated.

FIG. 20 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented as analphanumeric marking 372 placed on each of the luer connectors 328 ofthe extension legs 324. In the present embodiment, the letters “EtOH”are printed to indicate ethanol locking capability, though otherletters, words, symbols, numbers, etc., could be used to indicateethanol compatibility or another characteristic, quality, and/orproperty of the medical device.

FIG. 21 shows another example of an ethanol lock indicium 340, whereinthe indicium is implemented as an alphanumeric marking 382 disposed onthe tube of each extension leg 324. In the present embodiment, the words“ethanol lockable” are printed to indicate ethanol locking capability,though other combinations of letters, words, symbols, numbers, colors,etc., could be used, as before.

FIG. 22 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented in combination asan indicator piece 392A that is attached to or otherwise included withthe catheter assembly 10, together with an alphanumeric or othersuitable marking 392B included on the indicator piece. In theillustrated embodiment, the indicator piece 392A is shaped as a minipadlock indicating that the catheter assembly 10 is ethanol lockable. Inaddition, the alphanumeric marking 392B including an “e,” indicatingethanol lockability, is printed on the padlock-shaped indicator piece392A. Thus it is seen that, as in this and other embodiments, multiplemodes of indication, e.g., color, alphanumeric, iconic, symbolic, andshaped indicators, can be employed to convey to an observer thepredetermined characteristic, quality, and/or property of the catheteror medical device. In one embodiment, all or a portion of the indicatorpiece can be colored, such as in yellow, for instance. Or in anotherembodiment, the indicator piece includes no alphanumeric or iconicmarking.

Note that each of the two padlock-shaped indicator pieces 392A isslidably disposed about a corresponding one of the tubes of theextension legs 324. Though they can be fixably or movably included onother portions of the catheter assembly, it is appreciated that in oneembodiment the indicator pieces 392A are such that they do not interferewith either use of the device or patient comfort or safety. Note thatthe size, shape, color, number, location, and design of the indicatorpiece(s) can vary from what is shown and described here.

FIG. 23 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented in combination asan indicator piece 402A, together with an alphanumeric or other suitablemarking 402B included on the indicator piece. In the illustratedembodiment, the indicator piece 402A is cylindrically shaped and hollowso as to slidably fit over one of the tubes of the extension legs 324 ofthe catheter 320. In addition, the alphanumeric marking 402B includingthe letters “EtOH,” indicating ethanol lockability, is printed on thecylindrical indicator piece 402A.

FIG. 24 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented in combination asan indicator color marking 412A covering about half of each of twovalved connectors 408 disposed at the ends of the extension legs 324,together with an alphanumeric marking 412B placed on each of the valvedconnectors atop the indicator color markings 412A. In the illustratedembodiment, the indicator color marking 412A covering half of eachvalved connector 408 is yellow, though other colors and the coloring ofadditional or alternative catheter components is possible. Note that thebifurcation is also colored yellow to serve, as in previous embodiments,as a further component of the indicium 340 to indicate ethanolcompatibility. In addition, the alphanumeric marking 412B including theletters “EtOH,” also indicating ethanol lockability, is printed on thecylindrical indicator piece 402A.

FIG. 25 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented as a mixedalphanumeric/iconic marking 422 placed on each of the valved connectors408, as shown. In the illustrated embodiment, the mixed marking 422includes the letters “EtOH,” together with an iconic padlock imageincluding the letter “e” superimposed thereon, both indicating ethanollockability. In contrast, FIG. 26 shows the ethanol lock indicium 340 asincluding only an iconic marking 432 of a padlock image including theletter “e” superimposed thereon to indicate ethanol lockability,according to yet another embodiment.

FIG. 27 shows various examples of possible ethanol locking indicia 340according to one embodiment, including: a padlock icon with the letters“EtOH” superimposed thereon (442A); a padlock icon with a percentageconcentration of ethanol to be used with the medical device (442B); acolored padlock icon, marked in the color orange here (442C); a padlockicon including a keyhole (442D); a rounded padlock icon (442E); apadlock icon including a lowercase letter “e” superimposed thereon(442F); and a padlock icon including an uppercase letter “E”superimposed thereon (442G). Note these and the other markings andindicia discussed herein can be included with the catheter or medicaldevice in any one of a variety of ways including an adhesive or otherdecal or skin, ink-printed, a physical piece, etc., and can be appliedto any suitable portion of the device or component closely associatedtherewith via any suitable method, including direct surface application,pad printing, embossing, insert molding, over molding, etc.

FIG. 28 shows another example of an ethanol lock indicium 340 accordingto one embodiment, wherein the indicium is implemented as an iconicmarking 452 that includes a padlock image including the letter “e”superimposed thereon to indicate ethanol lockability. In the presentembodiment, the marking 452 is defined in a body 448 of a radiopaqueinsert 446 that is in turn included with an implantable access port. Inone embodiment the insert 446 is relatively thin and sheet-like andincludes a mixture of acetyl resin and bismuth trioxide, though manyother suitable materials can be used to define the insert. The marking452 in the present embodiment is defined as a cut-out through thesheet-like insert body 448 such that it provides a contrast to theinsert body when viewed via x-ray imaging technology after the accessport has been implanted into the body of the patient. Also optionallyincluded on the insert 446 is a power injection indicium 450, indicatingsuitability of the port for power injection of contrast media or otherfluids therethrough. Further details regarding the radiopaque insert andassociated access port can be found in U.S. Pat. No. 8,029,482, filedJun. 8, 2010, and entitled “Systems and Methods for RadiographicallyIdentifying an Access Port,” which is incorporated herein by referencein its entirety. Note that the size, shape, and configuration of theinsert can vary from what is shown and described herein. Note also thatthe type, size, configuration, purpose etc., of the ethanol lockindicium can also vary.

In light of the above, in one embodiment it is appreciated that theindicia discussed herein can be included with a component that isemployed or associated with the medical device rather than applied tothe medical device itself. This includes inclusion of the indicia on aluer cap or needle-less injection cap, for instance, each of whichoperably connects to the luer connectors of the catheter. As such, anyone or more of the indicia spoken above can be associated with such capsor other components employed with the catheter or other medical device.In one embodiment, it is further appreciated that the indicia can beformed so as to be radiopaque, thus enabling detection via x-ray imagingtechnology.

It is appreciated that, in light of the above, the indicia describedherein can be implemented in other ways, for other purposes thanindicating ethanol locking capability, and for other devices in additionto catheter assemblies. The above embodiments should therefore not beconsidered limiting in any way.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrative,not restrictive. The scope of the invention is, therefore, indicated bythe appended claims rather than by the foregoing description. Allchanges that come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A medical device for at least partial insertioninto a patient, the medical device comprising: a peripherally-insertedcentral catheter; a device body; and at least one ethanol indiciumincluded with the device body, the at least one ethanol indiciumperceptible by an observer to indicate a compatibility of the medicaldevice with ethanol or other alcohol-based substance, wherein the atleast one ethanol indicium includes at least one of an iconic markingincluding a symbol indicative of a lock and an alphanumeric markingindicative of the word “ethanol”.
 2. The medical device as defined inclaim 1, wherein the at least one ethanol indicium is visuallyperceptible by the observer.
 3. The medical device as defined in claim1, wherein the medical device includes the catheter defining at leastone lumen and wherein compatibility of the catheter indicates thatethanol can be disposed within the at least one lumen of the catheterwithout compromise to the functionality of the catheter.
 4. The medicaldevice as defined in claim 3, wherein the at least one ethanol indiciumincludes a coloring included on a bifurcation.
 5. The medical device asdefined in claim 4, wherein the coloring is substantially yellow andwherein the coloring is further included on at least one additionalcomponent of the catheter.
 6. The medical device as defined in claim 1,wherein the iconic marking includes a padlock image.
 7. The medicaldevice as defined in claim 1, wherein the at least one ethanol indiciumincludes shorthand indication for the word “ethanol”.
 8. The medicaldevice as defined in claim 1, wherein the at least one ethanol indiciumincludes a discrete indicator piece that is slidably attached to aportion of the catheter.
 9. The medical device as defined in claim 8,wherein the discrete indicator piece is slidably attached to anextension leg of the catheter.
 10. The medical device as defined inclaim 9, wherein the discrete indicator piece is one of a cylindricalshape and a padlock shape.
 11. The medical device as defined in claim 1,wherein the at least one ethanol indicium is disposed on a luerconnector of the catheter.
 12. The medical device as defined in claim 1,wherein the at least one ethanol indicium indicates a percentageconcentration of ethanol that the medical device can be acceptablyexposed to.
 13. The medical device as defined in claim 1, wherein the atleast one ethanol indicium is included on a tube clamp of an extensiontube of the medical device.
 14. A catheter for accessing an internalportion of a patient, comprising: a peripherally-inserted centralcatheter; a catheter tube defining at least one lumen; and at least oneethanol indicium included with the catheter, the at least one ethanolindicium perceptible by an observer to indicate a compatibility of thecatheter with ethanol; wherein the catheter further includes at leastone extension leg operably attached to the catheter tube via a coloredbifurcation, the colored bifurcation substantially colored yellow toserve as the at least one ethanol indicium; wherein each extension legfurther includes a tube clamp, at least one tube clamp being colored andfurther including an alphanumeric marking to also serve as the at leastone ethanol indicium; and wherein the alphanumeric marking includes theletters “ETOH” to indicate that the catheter can be fluid locked withethanol.